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FDA 510(k)

40 L HIGH FLOW INSUFFLATOR F113

K-Number: K060723 · 2006-05-25

ApplicantW.O.M. World of Medicine AG
Decision Date2006-05-25
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

40 L HIGH FLOW INSUFFLATOR F113 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine AG. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K060723. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 40 L HIGH FLOW INSUFFLATOR F113?

40 L HIGH FLOW INSUFFLATOR F113 is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is W.O.M. World of Medicine AG. The 510(k) number is K060723.

When did 40 L HIGH FLOW INSUFFLATOR F113 receive FDA 510(k) clearance?

40 L HIGH FLOW INSUFFLATOR F113 received FDA 510(k) clearance on 2006-05-25, under 510(k) number K060723.

Who is the listed applicant for 40 L HIGH FLOW INSUFFLATOR F113?

The FDA 510(k) record lists W.O.M. World of Medicine AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 40 L HIGH FLOW INSUFFLATOR F113?

The FDA product code for 40 L HIGH FLOW INSUFFLATOR F113 is HIF.

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Other records listing W.O.M. World of Medicine AG as applicant

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K123732HYSTEROSCOPY PUMP HM6K112642AQUILEX FLUID CONTROL SYSTEM H112K06336745L CORE INSUFFLATOR, MODEL F114K062380FLOSIMPLE ARTHROSCOPY PUMP A120K042457URO PROK03083740 L HIGH FLOW INSUFFLATOR F108

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Related Devices (Code: HIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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